BRCA1/2 Gene Patents Invalidated: Is it Finally about the Patient?
posted by Gaia Bernstein
Earlier this week a district court in a dramatic decision invalidated BRCA 1/2 – two breast cancer gene patents held by Myriad Genetics. The Court based its decision on patent subject matter analysis holding that since the isolated DNA covered by Myriad’s patents is not markedly different from the native DNA as it exists in nature, it qualifies as a product of nature, which is not patentable subject matter.
No doubt, as commentators have noted (here and here), this decision if not overturned or limited on appeal could carry broad ramifications for the future gene patents. But, this decision signifies also a change in strategy in the efforts to restrict gene patents – a focus on the patient.
As I have written, most of the debates on gene patents addressed the way that gene patents affect genetic research – the concern that granting patents on the building blocks of genetic science will hinder the development of more complex innovations. Unsurprisingly, most academic proposals and legislative bills address the innovation problem. The effects on the patient until now took a back seat.
This lawsuit against Myriad signifies a change in that it finally places the patient and the administration of genetic testing at the center of the stage. Although the Court’s holding focuses on patent subject matter the court dedicates a significant part of the opinion to access to BRCA1/2 genetic testing. Myriad charges about $3,000 for testing an exorbitant amount compared to other genetic tests. Furthermore, Myriad does not allow other laboratories to conduct the testing – all samples have to be sent to its headquarters in Salt Lake City. The opinion tells the stories of women who were unable to test to find out whether they carry the BRCA1/2 genes because Myriad would not accept their insurance. It recounts the ordeals of women who could not get definitive answers through Myriad’s testing and were precluded from seeking testing elsewhere. It underscores that women were unable to get a second opinion of the test results because tests are conducted only by Myriad. It also discusses the efforts of doctors and laboratories who were willing and able to offer BRCA1/2 testing but were precluded by Myriad from conducting the testing.
Although the Court’s analysis of patentable subject matter is not directly related to the issue of access, the detailed discussion of patients interests shows that these interests played a role in the Court’s decision. Myriad Genetics is not the only patent owner of genetic testing who hinders access to genetic testing technology. It would be interesting to see if this case will drive a strategic change in patent litigation and legislative proposals that have so far focused mainly on innovation and research in the area of genetics.
April 2, 2010 at 10:22 am
Tags: genetics, healthcare, Intellectual Property, patent
Posted in: Health Law, Intellectual Property
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Responses (7)
TJ - April 2, 2010 at 2:21 pm
I’m not sure this is a helpful development, and the tone of your post implies that you think it is. Patent law is, at its heart, an extremely cruel bargain: monopoly power (and consequently restricted quantity) for inventing things we otherwise might not get at all. How is this concern for patients any different from those people who are unable to afford HAART treatment because it costs $15k per year?
Pretty much all life-saving drugs can be produced for pennies if they were not patented, and giving patents thus means some unspecified number of people will be priced out and die. If the court here is being motivated primarily to strike down the patents because doing so will allow more patients to access the technology, then this decision has even broader ramifications than anybody first thought, since it threatens not only gene patents but all medicine-related patents.
Ken Arromdee - April 2, 2010 at 4:27 pm
“How is this concern for patients any different from those people who are unable to afford HAART treatment because it costs $15k per year?”
I don’t know what HAART treatment is, but in context I’d guess that it’s a treatment that either actually costs a lot of money to produce, or actually cost a lot of money to research and was novel in an everyday sense as well as in a legal sense.
The idea that patent is a bargain where you get a monopoly in exchange for inventing something we wouldn’t otherwise get only works if it really is something we otherwise wouldn’t get. Genes don’t work that way. The only thing “new” about a gene patent is that it’s being done to a different gene than the previous gene patent; it’s like patenting a container for water, then one for orange juice, then one for iced tea, etc. The only reason this company managed to patent the gene was that there has to be *some* first person to claim it, not that it was something unlikely to be invented without great expenditure or insight.
TJ - April 2, 2010 at 5:25 pm
Ken,
1. HAART is the treatment for AIDS patients, which has dramatically extended life expectancy for those who can afford it.
2. Whether the BRCA patents are “novel” in the everyday sense depends on how you look at it. Sure, the genes themselves are not novel. But the knowledge about how the genes work is, and deriving that knowledge required the “great expenditure” that you are talking about.
3. But, most importantly, the point about novelty is beside the point of this blog post. As I understand it, Gaia is saying that the academic discussion so far has been a dry bean-counting discussion of pioneering innovation versus subsequent innovation, with insufficient consideration of the plight of real human beings who die from lacking access to breast cancer screening. My point is that this kind of emotional appeal can be made against just about any medicine related patent, no matter how novel (in both the everyday and legal sense) the discovery might be.
Ken Arromdee - April 2, 2010 at 5:52 pm
The answer to that emotional appeal is that we have a choice between someone not being able to get the patented treatment… or nobody being able to get it because there are no incentives to spend a lot of money to research it.
That answer assumes that the research really does take a lot of money. If the treatment isn\’t novel, the answer doesn\’t work. Novelty is intimately tied with the emotional appeal.
Brett Bellmore - April 4, 2010 at 7:10 am
The knowledge necessary to know what gene variants to look for, to estimate likelihood of getting breast cancer, was novel. The knowledge necessary to test for those gene variants was not, the test is standard practice, with just the specific gene sequences changed. It’s the same mechanical procedure for any gene you’re testing for.
The problem is, Myriad didn’t originate the former knowledge. Not most of it, anyway. Gene samples were already available from people known to have a predispostion towards breast cancer, and the general area of the sample where the relevant gene was located was known, as was a typical sequence for the normal version of the gene. Myriad merely beat everybody else out in the race to sequence them, by running more machines. It was like having the name of the book, and the page number, and just beating somebody else to the library shelf. There wasn’t any novelty in what Myriad did, no invention.
The hard work had already been done by others.
Patents on existing genes have been dodgy from the start, and everybody has recognized this. It’s about time the courts did, too.
Dr. Shyamala Pillai Shah - April 12, 2010 at 1:35 am
I tend to agree with Gaia and Brett. The entire point of granting a patent is to safeguard interests of the inventor and to foster the spirit of innovation. Now, if the argument is that in doing so one must necessarily grant monopolistic rights to a company so we get access to treatments that would never have happened otherwise, seems to be sound. However, should this monopoly be misused so that the company can charge whatever it pleases just because it can? This seems to defeat the purpose of research which is supposed to benefit Human kind. Any kind of invention builds on knowledge acquired and shared by others coming before. While granting a patent may be a necessary step let us not allow it to deteriorate into a system by which greedy companies will always be beneficiaries and truly helpless patients will always be marginalized.
US District Court Rules Myriad Breast Cancer Patents Invalid: A New Frontier For Gene Patenting {Part I} - Biotechwiz - April 12, 2010 at 5:37 am
[...] the net I came across an interesting perspective on the judgement, I quote from the author’s post, “This lawsuit against Myriad signifies a change in that it finally places the patient and the [...]
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